| CTRI Number |
CTRI/2018/03/012482 [Registered on: 12/03/2018] Trial Registered Prospectively |
| Last Modified On: |
10/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of pretreatment with three different types of drugs in providing relief
from pain and withdrawal movements on injection of an Anaesthetic drug at the time of induction |
|
Scientific Title of Study
|
Evaluation of pretreatment with Lignocaine,
Dexmedetomidine or Ketamine in providing relief
from Propofol injection pain and withdrawal
movements during induction of Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karishma Batra |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi -110029, India
South
DELHI
110029
India |
| Phone |
9899902047 |
| Fax |
|
| Email |
karishmabatra05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Nayar |
| Designation |
Consultant and Profesor |
| Affiliation |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi -110029, India
South
DELHI
110029
India |
| Phone |
9971935269 |
| Fax |
|
| Email |
pavannayar1957@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Karishma Batra |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi -110029, India
South
DELHI
110029
India |
| Phone |
9899902047 |
| Fax |
|
| Email |
karishmabatra05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman Mahavir Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi -110029, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karishma Batra |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building
South
DELHI |
9899902047
karishmabatra05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients aged 18-65 years, of either sex, ASA grade I and II, BMI less than or equal to 30 kg/m2 , undergoing
elective surgical procedures under general anaesthesia with endotracheal intubation.
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE GROUP |
0.5 mcg/kg of dexmedetomidine diluted to 2ml of isotonic saline would be administered to the patient over 10 seconds, after manual
occlusion of the forearm, to ensure complete cessation of fluid infusion, over one minute,
followed immediately by propofol (1%) in a dose of 2 mg/kg body weight injected slowly
over the next 30 seconds. Every 5 seconds while injecting propofol, a doctor blinded to the
test solution would ask the patient to immediately grade any sensation of pain felt during
propofol injection using a 0-3 Scale( Verbal Rating Scale- VRS) by McCrirrick and Hunter
and the overall highest pain score would be recorded. Any withdrawal reaction would be
observed. |
| Intervention |
KETAMINE GROUP |
0.2 mg/kg of ketamine diluted in 2ml saline would be administered to the patient over 10 seconds, after manual
occlusion of the forearm, to ensure complete cessation of fluid infusion, over one minute,
followed immediately by propofol (1%) in a dose of 2 mg/kg body weight injected slowly
over the next 30 seconds. Every 5 seconds while injecting propofol, a doctor blinded to the
test solution would ask the patient to immediately grade any sensation of pain felt during
propofol injection using a 0-3 Scale( Verbal Rating Scale- VRS) by McCrirrick and Hunter
and the overall highest pain score would be recorded. Any withdrawal reaction would be
observed. |
| Comparator Agent |
LIGNOCAINE GROUP |
2ml of lignocaine would be administered to the patient over 10 seconds, after manual
occlusion of the forearm, to ensure complete cessation of fluid infusion, over one minute,
followed immediately by propofol (1%) in a dose of 2 mg/kg body weight injected slowly
over the next 30 seconds. Every 5 seconds while injecting propofol, a doctor blinded to the
test solution would ask the patient to immediately grade any sensation of pain felt during
propofol injection using a 0-3 Scale( Verbal Rating Scale- VRS) by McCrirrick and Hunter
and the overall highest pain score would be recorded. Any withdrawal reaction would be
observed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I & II
2. BMI less than or equal to 30 kg/m2
3. undergoing elective surgical procedures under general anaesthesia with endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1. History of pulmonary, renal, hepatic, endocrine, neurological or cardiovascular
disease(including hypertension, those on beta blockers or digitalis),patients on any
sedatives, anxiolytics or analgesics, history of drug abuse and psychiatric illness,
known hypersensitivity to the study drugs.
2. Pregnant and nursing females and emergency surgical procedures.
3. Subjects with anticipated difficulty in venous access. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the degree of alleviation of pain and withdrawal movements, with propofol injection
during induction of anaesthesia, using lignocaine, dexmedetomidine or ketamine as
pretreatment. |
At the time of induction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the variations in haemodynamic parameters. |
At the time of induction, preintubation , intubation and post intubation. |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/03/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Tan CH, Onsiong MK. Pain on injection of Propofol. Anaesthesia. 1998;53:468-476.
2. Stark RD, Binks SM, Dutka VN, O’ Connor KM, Arnstein M J A, Glen J B. A review
of the safety and tolerance of Propofol (Diprivan). Postgrad Med J.1985; 61:152-156.
3. Mangar D, Holak EJ. Torniquet at 50mm Hg followed by intravenous Lidocaine diminishes hand pain associated with Propofol injection. AnesthAnalg.1992;74:250-
252. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1.To study the degree of alleviation of pain and withdrawal movements, with propofol injection during induction of anaesthesia, using lignocaine, dexmedetomidine or ketamine as pretreatment. 2.To study the variations in haemodynamic parameters.
HYPOTHESIS : Pretreatment with dexmedetomidine would be comparable to ketamine and lignocaine in providing relief from pain and withdrawal movements associated with propofol injection during induction of anaesthesia. |